《心血管疾病介入诊疗技术管理规范》

《心血管疾病介入诊疗技术管理规范》 心血管疾病介入诊疗技术管理规范 为规范心血管疾病介入诊疗技术临床应用～保证医疗质量和医疗安全～制定本规范。本规范为医疗机构及其医师开展心血管疾病介入诊疗技术的最低要求。 本规范所称心血管疾病介入诊疗技术是指经血管穿刺径路进入心腔内或血管内实施诊断或者治疗的技术～不包括以抢救为目的的临时起搏术、床旁血流动力学监测、主动脉内球囊反搏术。 一、医疗机构基本要求 ,一,医疗机构开展心血管疾病介入诊疗技术应当与其功能、任务相适应。 ,二,三级医院～有卫生行政部门核准登记的心血管内科、心脏大血管外科或者胸外科的诊疗科目～有血管造影室和重症监护室。 ,三,心血管内科 开展心血管内科临床诊疗工作5年以上～床位不少于40张～其技术水平达到三级医院心血管内科专业重点科室技术标准～在本省、自治区、直辖市三级医院中处于领先地位。 ,四,心血管外科或者胸外科 开展心血管外科或者胸外科临床诊疗工作5年以上～床application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 位不少于30张～其技术水平达到三级医院心血管外科或者胸外科专业重点科室技术标准～在本省、自治区、直辖市三级医院中处于领先地位。 ,五,血管造影室 1.符合放射防护及无菌操作条件。 2.配备800mA～120KV以上的心血管造影机～具有电动操作功能、数字减影功能和“路途”功能～影像质量和放射防护条件良好,具备医学影像图像管理系统。 3.有主动脉内球囊反搏器。 4.能够进行心、肺、脑抢救复苏～有氧气通道、麻醉机、除颤器、吸引器等必要的急救设备和药品。 5.有存放导管、导丝、造影剂、栓塞剂以及其他物品、药品的存放柜～有专人负责登记保管。 6.开展心内电生理检查和心律失常介入治疗还应当配备八导联以上,含八导联,的多导电生理仪。 ,六,重症监护室 1.设置符合规范要求～达到III级洁净辅助用房标准～病床不少于6张～每病床净使用面积不少于15平方米～能够满足心血管疾病介入诊疗专业需要。 2.符合心血管内科、心血管外科或者胸外科专业危重病人救治要求。 3.有空气层流设施、多功能监护仪和呼吸机～多功能监application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 护仪能够进行心电图、血压和血氧等项目监测。 4.能够开展有创监测项目和有创呼吸机治疗。 5.有经过专业的、具备5年以上重症监护工作经验的专职医师和护士。 ,七,其他辅助科室和设备 1.医学影像科能够利用多普勒超声心动诊断设备进行常规检查和无创性心血管成像与血流动力学检查。 2.有磁共振,MRI,、计算机X线断层摄影,CT,和医学影像图像管理系统。 ,八,有至少2名具备心血管疾病介入诊疗技术临床应用能力的本院在职医师～有经过心血管疾病介入诊疗相关知识和技能培训的、与开展的心血管疾病介入诊疗相适应的其他专业技术人员。 二、人员基本要求 ,一,心血管疾病介入诊疗医师 1.取得《医师执业证》～执业范围为内科专业或者外科专业。 2.有3年以上心血管内科、心脏大血管外科或者胸外科临床诊疗工作经验～具有主治医师以上专业技术职务任职资格。 3.经过卫生部认定的心血管疾病介入诊疗培训基地系统培训并考核合格。 application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 4.经2名以上具有心血管疾病介入诊疗技术临床应用能力、具有主任医师专业技术职务任职资格的医师推荐～其中至少1名为外院医师。 ,二,其他相关卫生专业技术人员 经过心血管疾病介入诊疗相关专业系统培训并考核合格。 三、技术管理基本要求 ,一,严格遵守心血管疾病介入诊疗技术操作规范和诊疗指南～根据患者病情、可选择的治疗、患者经济承受能力等因素综合判断治疗措施～因病施治～合理治疗～严格掌握心血管疾病介入诊疗技术的适应症。 ,二,心血管疾病介入诊疗由2名以上具有心血管疾病介入诊疗技术临床应用能力的、具有副主任医师以上专业技术职务任职资格的本院在职医师决定～术者由具有心血管疾病介入诊疗技术临床应用能力的本院医师担任～术后制定合理的治疗与管理方案。 ,三,实施心血管疾病介入诊疗前～应当向患者和其家属告知手术目的、手术风险、术后注意事项、可能发生的并发症及预防措施等～并签署知情同意书。 ,四,建立健全心血管疾病介入诊疗后随访制度～并按规定进行随访、记录。 ,五,在完成每例次心血管病介入诊疗后10个工作日application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 内～由术者使用卫生部规定的软件～将有关信息报送至卫生部及省级卫生行政部门。 ,六,医疗机构每年完成的心血管疾病介入诊疗病例不少于200例～其中治疗性病例不少于100例,无与心血管疾病介入诊疗手术相关的医疗事故～血管造影并发症发生率低于0.5%～心血管疾病介入诊疗技术相关死亡率低于0.5%。 ,七,具有心血管疾病介入诊疗技术临床应用能力的医师作为术者每年完成心血管疾病介入诊疗病例不少于50例。 其中～从事冠心病介入治疗的医师作为术者每年完成冠心病介入治疗不少于50例,从事导管消融治疗的医师作为术者每年完成导管消融治疗不少于20例,从事起搏器治疗的医师作为术者每年完成起搏器治疗不少于10例,从事先天性心脏病介入治疗的医师作为术者每年完成先天性心脏病介入治疗不少于20例。 ,八,医疗机构和医师按照规定定期接受心血管疾病介入诊疗技术临床应用能力～包括病例选择、手术成功率、严重并发症～死亡病例～医疗事故发生情况～术后病人管理～病人生存质量～随访情况和病历质量等。 ,九,其他管理要求 1.使用经药品监督管理部门审批的心血管疾病介入诊疗器材～不得通过器材谋取不正当利益。 2.建立心血管疾病介入诊疗器材登记制度～保证器材来application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 源可追溯。在心血管疾病介入诊疗病人住院病历中手术记录部分留存介入诊疗器材条形码或者其他合格证明文件。 3.不得违规重复使用一次性心血管疾病介入诊疗器材。 4.严格执行国家物价、财务政策～按照规定收费。 四、培训 拟从事心血管疾病介入诊疗的医师应当接受至少1年的系统培训。 ,一,培训基地 由卫生部指定～且具备下列条件: 1.三级甲等医院。 2.具备心血管疾病介入诊疗技术临床应用能力～每年完成各类心血管疾病介入诊疗病例不少于1000例～其中治疗性病例不少于500例。 冠心病介入诊疗培训基地每年完成各类心血管疾病介入诊疗病例不少于1000例～其中冠心病介入治疗病例不少于200例。 心律失常介入诊疗培训基地每年完成各类心血管疾病介入诊疗病例不少于1000例～其中导管消融治疗病例不少于150例～永久起搏器植入治疗病例不少于70例。 先天性心脏病介入诊疗培训基地每年完成各类心血管疾病介入诊疗病例不少于1000例～其中先天性心脏病介入治疗病例不少于70例。 application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 3.心血管内科和心脏大血管外科或者胸外科床位总数不少于150张。 4.有至少4名具有心血管疾病介入诊疗技术临床应用能力的指导医师～其中至少2名为主任医师。 5.有与开展心血管疾病介入诊疗培训工作相适应的人员、技术、设备和设施等条件。 6.近3年在国内核心专业杂志或科学引文索引,SCI,期刊发表有关心血管疾病介入诊疗的学术论文不少于15篇或出版临床专著。 7.举办过全国性的专业学术会议或承担国家级继续医学教育项目。 ,二,培训基地基本要求 1.培训教材和培训大纲经卫生部认可。 2.保证接受培训的医师在规定时间内完成规定的培训。 3.培训结束后～对接受培训的医师进行考试、考核～并出具是否合格的结论。 4.为每位接受培训的医师建立培训及考试、考核档案。 5.根据实际情况和培训能力决定培训医师数量。 ,三,心血管疾病介入诊疗医师培训要求 1.在上级医师指导下～参与完成不少于25例诊断性心导管检查、心血管造影病例和不少于15例心血管疾病介入治疗病例～并经考核合格。 application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 拟从事冠心病介入治疗的医师～在上级医师指导下～参与完成不少于50例冠状动脉造影病例和不少于25例冠心病介入治疗病例～并经考核合格。 拟从事导管消融治疗的医师～在上级医师指导下～参与完成不少于20例导管消融治疗病例～并经考核合格。 拟从事起搏器治疗的医师～在上级医师指导下～参与完成不少于10例起搏器治疗病例～并经考核合格。 拟从事先天性心脏病介入治疗的医师～在上级医师指导下～参与完成不少于15例先天性心脏病介入治疗病例～并经考核合格。 2.在上级医师指导下～参加对心血管疾病介入诊疗患者的全过程管理～包括术前评价、诊断性检查结果解释、与其他学科共同会诊、心血管疾病介入诊疗操作、介入诊疗操作过程记录、围手术期处理、重症监护治疗和手术后随访等。 3.在境外接受心血管疾病介入诊疗系统培训6个月以上、完成规定病例数的医师～有培训机构的培训证明～并经培训基地考试、考核合格～可以认定为达到规定的培训要求。 五、其他管理要求 本规范实施前具备下列条件的医师～可以不经过培训和心血管疾病介入诊疗技术临床应用能力评价开展心血管疾病介入诊疗: 1.职业道德高尚～同行专家评议专业技术水平较高～并application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 获得2名以上本专业主任医师的推荐～其中至少1名为外院医师。 2.在三级医院连续从事心血管疾病介入诊疗临床工作10年以上～具有副主任医师以上专业技术职务任职资格。 3.近5年累计独立完成心血管疾病介入诊疗病例300例以上～且未发生二级以上与心血管疾病介入诊疗相关的医疗事故～血管造影并发症发生率低于0.5%～心血管疾病介入诊疗相关死亡率低于0.5%。 除上述条件外～拟从事冠心病介入治疗的医师近5年累计独立完成冠心病介入治疗病例200例以上。 拟从事导管消融治疗的医师近5年累计独立完成导管消融治疗病例100例以上。 拟从事起搏器治疗的医师近5年累计独立完成起搏器治疗病例50例以上。 拟从事先天性心脏病介入治疗的医师近5年累计独立完成先天性心脏病介入治疗病例50例以上。 application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check